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The Future of BioPharma blog provides timely coverage of news that directly impacts the business strategies of the biotech, pharmaceutical and medical device industries. In addition to news coverage, the Future of BioPharma blog features live event coverage from IIR's Biopharmaceutical and Healthcare division.

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Wednesday, October 14, 2015

Biobanks are biomedical research facilities that process and stores a wide variety of biospecimens, to include whole tissue, blood, DNA, plasma, purified saliva, cell lines, stem cell populations, and more. The goal of biobanking is to preserve biological samples for storage, and importantly, potential use at a later point in time. Biobanks are now playing a major role in assisting pharmaceutical companies with drug discovery and development efforts. They are also driving forward precision medicine efforts, as they have the capacity to allow physicians to select the best treatment option for specific patients. However, effectively preserving tens of thousands, or even hundreds of thousands, of biological samples can be a daunting task.

To honor this growing industry, speakers at the “Biorepositories and Sample Management Summit” held today at the Hilton Hotel in Boston, Massachusetts delivered a jam-packed day of content.

We heard presenters discuss biobanking topics that included:

• A trend toward broader consent procedures
• Approaches to sample sourcing
• Price negotiation techniques for sample acquisition
• Traditional and non-traditional methods of acquiring patient consent
• How to determine patient identify when using online consent methods
• Financial planning models and web-based applications to assist business planning
• The importance of monitoring sample quality over time
• And much more

Clearly, the biobanking industry is moving rapidly in new directions.

Drs. Miranda and Yanak discussed the growing importance of the industry by stating, “Biobanking is no longer just storage; it incorporates the entire product lifecycle.” They spoke about biobanks moving from “giant freezer farms” to now function as “facilities that provide much needed services to drug development companies, from the start to the finish of the process.” They also highlighted the importance of evaluating specimen value and quality over time, including the effect of long-term storage and the impact of freeze-thaw cycles.

Dr. Beth Karlson of Brigham and Women’s Hospital and Harvard Medical School wins my award for "Best Talk of the Day" for her presentation on the important and controversial topic of implementing “Electronic Informed Consent (eIC)." This novel approach to consent has the potential to transform the biobanking industry, a community that has traditionally relied on paper-based methods and in-person consent procedures. At Partners Healthcare, Dr. Karlson’s team is achieving electronic consent rates as high as 3.5%, by emailing individuals through their Patient Portal System.

Dr. Sandra Gaston also gave a fascinating talk on tissue print technologies and how the approach can expand the range and representation of biospecimens that are available for analysis. She used prostate cancer as her example case, but the technique can can be applied to biospecimens for breast cancer, ovarian cancer, and more. Importantly, she highlighted that tissue print technologies can be used obtain high quality samples from biospecimens, like tissue biopsies, that would usually be too small to be sampled by traditional methods.

Dr. Brian Hart of Ventana Medical Systems-Roche spoke on the topic of “Moving Toward Strategic Partnerships with Biospecimen Providers,” in which he introduced the novel concept of using an online auction to collect bids from multiple vendors when large sample quantities are required. Through his case study, he demonstrated that pricing stability can be introduced into an otherwise volatile marketplace and that vendor bids can be driven down by as much at 50%. He also wins my award for the best quote of the day by stating, “Nothing gets done without the biospecimen.” With this pity statement, he highlighted that the biospecimen is the beginning of all research and development activities that are designed to create safer and more effective treatment options for patients.

In summary, major trends that were explored during the conference today included:

1. Could biobanks potentially have the ethical responsibility to “return” clinical findings to patients in the future? Will ethics committees (EC) gradually move in this direction in the future?
2. How can the biobanking community best broaden consent language to incorporate all potential future uses for biospecimens, including future technologies that may not yet exist?
3. How can the biobanking industry standardize pricing of biospecimens? Is it possible to introduce pricing stability into the industry at large? Is it the obligation of the biospecimen vendor or the buyer to establish reasonable cost parameters?
4. Can equal (or potentially even higher) rates of patient consent for biobanking be achieved through electronic communication, such as sending emails through a healthcare provider’s Patient Portal System (PPS)? Will electronic informed consent (eIC) gradually replace traditional in-person methods? Will these electronic methods be legally robust approaches that will stand the test of future litigation?
5. Can cost modeling and web-based applications be used to improve cost recovery at biobanks? Will biobanks be willing to integrate this technology to assist with business planning?